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26. 1. H. C. Neu, in Human Pharmacology, L. E. Wingard, Jr., T. M. Brody, J. Lemer, A. Schwartz, Eds. 27. Mosby-Year Book, New York, 1991 ; , pp. 613 * 28. 698. 2. , Am. J. Med. 76 Suppl. 5A ; , 11 1984 M 29. Finland, Rev. Infect. Dis. 1, 14 1979 D. R. Schaberg et aL, Am. J. Med. 70, 445 1981 D. 30. Milatovic and I. Braveny, Eur. J. Chn. Microbiol. 6, 234 1987 ; . 3. L. Bryan, J. Antimicrob. Chemother. 22 suppl. A ; , 1 1988 ; . 4. J. Shapiro, Ed., Mobile Genetic Elements Academic Press, New York, 1983 ; . 31. 5. J. Bruton et al., J. Bacteriol. 168, 374 1986 J. 32. Bruton et al., Rev. Infect. Dis. 8, 713 1986 ; . 33. 6. A. Brisson-Noel, M. Arthur, P. Courvalin, J. Bac, because prednisolone liquid.
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Objetive: To compare the analgesic efficacy of methylprednisolone corticoid ; versus diclofenac nonsteroidal antiinflammatoryNSAID- ; after surgical removal of lower third molars. Study Design: Prospective study on 73 patients for the surgical removal of their lower third molars. These patients were separated in two groups at random: a diclofenac group and a methylprednisolone group. A record card was filled in with preoperative and postoperative epidemiological and clinic data. The pain level assessment was made on a semiquantitative and an analogical visual scales and in relation to the amount of rescue analgesics consumed. Pain levels were measured at 1, 8, 24, and 72 hours. In order to make a broad study of data, BMDP program was used for statistics. Results: In the pain described by patients in the analogical visual scale there were no differences between groups as a whole. There were no differences in the amount of rescue analgesics consumed. Conclusions. There is less pain in the corticoid group but not as to justify its routine use. Key words: Oral surgery third molars, methylprednisolone, diclofenac, pain.
Concerns about the foreskin prepuce ; , balanitis or penile inflammation are very commonly seen in general practice. WOMEN'S HEALTH, for example, prednisolone 1.
160; there have been spontaneous or published reports of cyp3a based interactions of erythromycin and or clarithromycin with cyclosporine, carbamazepine, tacrolimus, alfentanil, disopyramide, rifabutin, quinidine, methylprednisolone, cilostazol, and bromcriptine.
Wptv, gender can affect your reaction to medications - sep 4, 2007 prednisolone - a steroid treatment for asthma - is less effective when progesterone levels are high, meaning meds leave a woman' s system faster and leave abc com, thyroid disease - sep 6, 2007 if theres no improvement after a week, prednisolone 40-60mg ; may be given and tapered over four to six weeks and protonix.
A summary of the clinical features of the patients who were admitted to the Prince of Wales Hospital from June 1994 to August 1997 with necrotising fasciitis caused by Vibrionaceae is shown in Table 1. The presentation of all six cases of necrotising fasciitis was similar. All patients presented with a primary complaint of swelling and tenderness of an extremity.
The effects of the novel NO releasing synthetic glucocorticoid NCX-1015 on GR activation and inflammation were assessed. U937 cells incubated with NCX-1015 10 mM ; resulted in a profound enhancement of GR binding not seen with prednisolone. This manifested itself in faster dissociation 0.5 h ; of hsp90 from GR and resulted in a quicker translocation of GR from the cytoplasm to the nucleus. Treatment of U937 cells with NCX-1015 1-10 mM ; caused a rapid 0.5 h ; nitration of GR, which was not observed after vehicle incubation. Finally, NCX-1015 had an enhanced antiinflammatory profile compared with prednisolone in models acute and chronic inflammation including collagen IIinduced arthritis ; . In conclusion, post-translational modification of GR by this novel nitro-steroid is responsible, at least in part, for its enhanced anti-inflammatory activity. Key words: glucocorticoids nitric oxide inflammation and theo-dur.
A participating pharmacy you will be responsible for the applicable copayment plus the difference between the allowable charge for the generic equivalent and the allowable charge for the brand name drug. v At a non-participating pharmacy you pay the total price for the drug and then file a Prescription Drug Direct Reimbursement Claim Form. Reimbursement is limited to the allowable charge for the generic drug minus your copayment. To obtain prescriptions at a participating retail pharmacy simply: 1. Present your Trigon health care identification card to your pharmacist. 2. Pay the appropriate copayment. The pharmacist will tell you the amount of your copayment. 3. If you request a brand name drug when a generic is available, you pay the appropriate copayment plus the difference between the generic and the brand name allowable charge. Note: Some drugs require Prior Authorization before they are dispensed. See Approval of Care At A Glance, page 2.
1st dam TIDY WAGER IRE ; : winner at 4 and placed twice inc. 2nd Ladbrokes Ext. H., Curragh ; dam of 1 previous foal, a yearling filly by Indian Danehill IRE ; . 2nd dam OFTEN: unraced; dam of 11 winners inc.: Outeniqua: 2 wins at 3 and placed 4 times; dam of 3 winners inc.: ASCENSION IRE ; : 4 wins at 2 and 3 at home and in France and 74, 969 inc. Prix d'Astarte, Gr.2, Prix du Calvados, Gr.3 and Rose Bowl S., L., placed 2nd Prix des Reservoirs, Gr.3. Eko Bluebird Angel IRE ; : 3 wins at 2 and 3 in Denmark and in Sweden and 35, 942 and placed 3 times; dam of a winner. Lady Cat's Eye IRE ; : 3 wins at 3 and 4 in Japan and 116, 233. Often Ahead IRE ; : 2 wins and placed 6 times; broodmare. 3rd dam Time To Leave by Khalkis ; : 2 wins at 3 and placed twice inc. 2nd Bedford Guineas Trial S.; dam of 4 winners inc.: FOILED AGAIN: 3 wins inc. Sandleford Priory S., L., 3rd Prix Saint-Alary, Gr.1, Nassau S., Gr.2 and Ribblesdale S., Gr.2; dam of 5 winners inc.: CUT NO ICE: 2 wins at 3 and 4 at home and in France inc. Prix Sir Gallahad, L.; dam of Country Club GB ; 4 wins at 2 and 3 in Poland, 3rd BMW Europachampionat, Gr.2 ; , Subzero GB ; 4 wins, 43, 405 viz. 2 wins at 2 and 3 and placed inc. 3rd Winalot National S., L.; also 2 wins in Denmark and placed inc. 3rd Taby Open Sprint Championship, L. ; . Bold Caress: winner at 3 and placed viz. 2nd Azalea S., L.; dam of 4 winners inc.: HOMO SAPIEN: 4 wins and 54, 268 inc. Abernant S., L., placed inc. 2nd John of Gaunt S., L., Harroways S., L., 3rd Ricard Challenge S., Gr.3; sire. Classic Minstrel USA ; : 2 wins viz. winner and placed viz. 2nd Ballysax S., L.; also winner in France and placed 4 times. 4th dam DAWN CHORUS: ran 3 times at 2 and 3; dam of 4 winners inc.: IRISH CHORUS: 5 wins at 2 inc. Phoenix S.; dam of 5 winners inc.: SARITAMER USA ; : Champion 3yr old sprinter in England in 1974, 8 wins at 2 and 3 and 27, 050 inc. Beresford S., Gr.2, July Cup, Gr.2, Anglesey S., Gr.3, Cork and Orrery S., Gr.3, Diadem S., Gr.3; sire. Hawaiian Dawn USA ; : winner in U.S.A.; dam of HAWAIIAN IMAGE JPN ; won Satsuki Sho 2000 Guineas ; , Gr.1, Fukushima Kinen, Gr.3, Radio Tampa Sho, Gr.3; sire ; , MEIWA KIMIKO JPN ; won Sprinters S., Gr.3 twice , PRO MADE JPN ; won Kabutoyama Kinen, Gr.3 ; . El Galgo: winner at 3; grandam of GAROZZO won Premio d'Estate, Gr.3 fourth dam of RISKY GB ; 5 wins at 2 inc. Molecomb S., Gr.3 ; . Stabled in Barn S Box 7 and ventolin.
Serial coronary angiograms were performed using the identical projection, tube and table height, and magnification. The non-ionic contrast medium iopromide Ultravist 370, Schering ; was used for angiography and was injected manually through the guiding catheter at low pressure. Biplane cineangiograms were recorded with the target vessel positioned near the isocenter. Overlapping of coronary segments was avoided. The film sequences were stored digitally for subsequent computer analysis. The coronary luminal diameter was analyzed by the use of an automated edge-detection software system CAAS II, Pie Medical ; . The analysis was performed by a trained investigator who was unaware blinded ; of the investigated subject, of the study medication, and of the intracoronary infusions. The contrast medium-filled distal 7-French guiding catheter was used as the standard for calibration. The mean luminal diameter of the target vessel was measured at a segment proximal to the infusion catheter control segment ; , at the tip of the Doppler wire before and after nitroglycerin infusion and before and after adenosine infusion for the calculation of coronary blood flow, and in three subsequent vessel segments distal to the Doppler wire before and after administration of each successive dose of acetylcholine. For the comparison of the coronary response to acetylcholine, the combined response of all three analyzed vessel segments was used. The response of the vessel segment was calculated as percent change in mean luminal diameter compared with the baseline measurement. Negative values indicate decreases in luminal diameter.
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Initially, give salbutamol 6 puffs children under 6 years ; or 12 puffs children 6 years and over ; . Review response after 20 minutes and repeat if necessary as for moderate acute episodes. Consider beginning a short course of oral corticosteroids prednisolone 1 mg kg daily for up to 3 days ; . Observe for at least 20 minutes after the last dose before allowing the child to go home.
E21R is a modified form of granulocyte macrophage stimulating colony factor GM-CSF ; , a naturally occurring protein involved in the formation and function of developing blood cells. To regulate these processes in healthy cells, the protein binds to a receptor on the cell surface. This activates the receptor to deliver signals to the cell to promote cell survival, stimulate cell proliferation and to activate various cellular functions. Note: This product is added upon acquisition of British Biotech plc. Acute Myelogenous Leukemia Granulocyte-macrophage colony-stimulating factor receptor GM-CSFr ; Antagonist D July 23, 2002 British Biotech and BresaGen Ltd announced that they have terminated their collaborative agreement to develop the GM-CSF antagonist E21R. British Biotech has stopped a Phase II clinical study of E21R in AML patients. In addition, the Company has now been advised by external experts that, in view of the new preclinical data, a proposed Phase I clinical study in children with various myeloid leukaemias could not proceed on ethical grounds. This proposed study was considered to be a pre-requisite for efficacy studies in the rare childhood disease, juvenile myelomonocytic leukaemia. 9 22 2005 and differin.
Shortness of breath decreased to a greater extent with nebulised steroids, pulmonary function testing seemed to favour prednisolone; there was no significant difference between the two drugs. None of the studies looked specifically at side effects; however all suggested that short courses were safe when treating acute exacerbations of asthma. Formal evaluations of safety were not made. Ptednisolone takes effect within 1-4 hours, and its half-life is 12-30 hours. Subsequently effects may be seen initially, and then gradually decrease. Additionally pulmonary function testing is difficult in young children. There is generally insufficient research on nebulised steroids, and none of the studies included those requiring intensive care or in status asthmaticus, which may be applicable in the developing world. Additionally no studies included patients already taking steroids for treatment of chronic asthma, so findings may not apply to these patients. This review concluded that there is little difference between corticosteroids as they all have approximately similar benefits, including early discharge and improving symptom scores. Emergency treatment of an acute asthma exacerbation with prednisolone seems to result in earlier recovery of illness.
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The effect of glucocorticoid hormones on renal function is of importance because of the striking alterations which occur in adrenal insufficiency and the widespread pharmacological use of these agents in patients with intact adrenal function. Previous studies, in the absence of adrenal insufficiency, have suggested that glucocorticoid hormones increase glomerular filtration rate 1, 2 ; and free water clearance 3, 4 ; and may influence the tubular reabsorption of sodium 5, 6 ; . In the present study the action of methylprednisolone on sodium reabsorption by the renal tubule was examined in normal rats under conditions of acute and chronic administration by clearance and micropuncture techniques. In addition, since glucocorticoid.
Undergoing HCA with or without retrograde cerebral perfusion are lacking. Although it is difficult to interpret the data obtained during HCA, those obtained during reperfusion are of great importance. Unfortunately, because we performed SCP routinely for aortic arch repair, we have no concrete comparative data during HCA. Second, steroid doses were not identical in the two groups and varied within the CPB-group. The administration of steroids may attenuate an increase in the permeability of the BBB associated with CPB [23], thereby reducing the leakage of S100 through the BBB. Our previous studies also showed a large gradient in proinflammatory cytokines interleukin-8 ; [24] or S100 [25] between cerebrospinal fluid and serum in patients undergoing thoracoabdominal aortic surgery and given the same dose of steroids. We must take into account that the patients in the SCP-group were given a higher dose of steroids than those in the CPB-group. In the CPB-group, there was no significant difference in arterial S100 between the patients given 500mg of methylprednisolone and those given 2000mg of methylprednisolone at any time data not shown ; . Furthermore, the larger initial dilution ratio to prime the CPB circuit in the SCP-group might result in smaller differences in the S100 levels than the true values in the two and feldene.
This leads to a cycle of poor caregiving followed by reduced functioning in the patient. In one study, caregivers reported that among the most distressing aspects were the psychological impact of MS on the patient and the incurability of the disease. Most caregivers identified the best form of support to be practical help, cooking, cleaning, and better availability of medical and financial advice. Therapeutic help for family members may also be helpful.
H. AL-SARDAR Department of Medicine, Southend General Hospital Southend-on-Sea, Essex SS0 0RY, UK Email: halsardar hotmail and frusemide.
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Kutapressin, up to 2 Leucovorin Calcium, per 50 mg Leuprolide Acetate for depot suspension ; , 7.5 mg Lupron ; 22.5 mg allowed for DX 185 only ; Leuprolide Acetate for depot suspension ; , per 3.75 mg Lupron ; Leuprolide Acetate for depot suspension ; , per 11.25 mg Lupron ; 3 months ; Leuprolide Acetate, per 1 mg Lupron ; Levocarnitine per 1 gm Levofloxacin 250 mg ; Levorphanol tartrate, up to 2 mg Lidocaine HCL, 50 cc Lincomycin HCL, up to 300 mg Lincocin ; Lorazepam, 2 mg Ativan ; Lupron Depot Pediatric 11.25 mg Lupron Depot Pediatric 15 mg Lupron Depot Pediatric 7.5 mg Magnesium Sulfate, 500 mg, injection Mannitol, 25% in 50 ml Mechlorethamine Hydrochloride Nitrogen Mustard ; , 10 mg Medroxyprogesterone Acetate for Contraceptive Use, 150 mg Depo-Provera ; Medroxyprogesterone Acetate, 100 mg Depo-Provera ; Melphalan Hydrochloride 50 mg Alkeran ; Meperidine and Promethazine HCL, up to 50 mg Mepergan Injection ; Meperidine Hydrochloride, per 100 mg Demerol HCL ; Mephentermine, up to 30 mg Mepivacaine Carbocaine ; 10 ml Mesna, 200 mg Mesnex ; Metaraminol Bitartrate 10 mg Aramine ; Methadone HCL, up to 10 mg Methicillin Sodium, up to 1 gm Staphcillin ; Methocarbamol, up to 10 ml Robaxin ; Methotrexate Sodium, 5 mg Methotrexate Sodium, 50 mg Methotrimeprazine, up to 20 mg Methoxamine, up to 20 mg Vasoxyl ; Methyldopate HCL, up to 250 mg Aldomet ; Methylergonovine Maleate, up to 0.2 mg Methergine ; Methylprednisolone Acetate, 20 mg Depo Medrol ; Methylprednisolone Acetate, 40 mg Methylprednisolone Acetate, 80 mg Methylprednisolone Sodium Succinate, up to 125 mg SoluMedrol, Anetha Pred ; Methylprednisolone Sodium Succinate, up to 40 mg Solu Medrol, Anetha Pred ; Metoclopramide HCL, up to 10 mg Reglan and keflex and prednisolone.
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Flow rate PEFR ; at home Fig. 286 ; . This is a measure of the amount of air the patient can blow into a peak flowmeter from fully inflated lungs and is measured in liters per minute. The patient determines his or her normal PEFR during symptom-free times. If the PEFR begins to fall below the patient's personal norm, treatment that has been predetermined with the health care provider should be initiated. Readings can be charted to keep track of progress Fig. 287 ; . Often PEFR results indicate the onset of asthma before the patient experiences any symptoms Home Health Hints.
Of special note, the studies showed that the new drug may be more effective than existing drugs in lowering so-called systolic blood pressure, the top number obtained when a patient's blood pressure is measured and nifedipine.
We all know about the negative things, i.e.: smoking, overeating, physical inactivity, etc. That doesn't seem to motivate people. What more positive motivations can we use? It seems we have framed our arguments in the negative. As we age, there is such outright joy in maintaining our strength and ability to hike, walk, etc. Fruits and vegetables and the avoidance of higher fat foods allow us to sleep better and to feel more like participating in those activities.
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Survival was 75% and 71%, respectively. Seven patients died between 2 days and 18 months after transplantation. The causes of death and graft loss are shown in Tables 2 and 3, respectively. Renal function The mean serum creatinine at 1 year and 2 years was 2.0 and 2.2 mg dL, respectively, and calculated creatinine clearance was 55 and 40 mL min, respectively Fig. 1 ; . Acute rejection Acute rejection was diagnosed in 9 22% ; recipients and treated with methylprednisolone; 2 with combined.
Figure 1 plasma concentration of alanine aminotransferase in 9 patients with aih before after 18 range 12-37 ; mo treatment with tacrolimus in addition to prednisol0ne and azathioprin or mycophenolate mofetil.
Drug Name * lutera LUXIQ MAXIFLOR MEDROL * medroxyprogesterone acetate MENEST MENOSTAR * meprolone unipak METHERGINE METHITEST * methylprednisolone MIACALCIN * microgestin * microgestin fe MIRCETTE MODICON * mometasone furoate * mononessa MUSE * nature-throid * necon * nora-be NORDETTE-28 NORDITROPIN NORDITROPIN NORDIFLEX * norethindrone acetate NORINYL 1 + 35 NORINYL 1 + 50 NOR-Q-D * nortrel NOVACORT NUTRACORT 1% LOTION * nutracort 2.5% lotion NUTROPIN NUTROPIN AQ NUTROPIN DEPOT NUVARING NUZON Tier 1 2 None None None None None None None None None None PA PA PA None None None None PA PA None None None None None None None None None None None QL Requirements and Limits None None None None None None QL and protonix.
61 A randomised phase II feasibility study of Docetaxel Taxotere ; plus Prednisolon4 vs. Docetaxel Taxotere ; plus Prednisolond plus Zoledronic acid Zometa ; vs. Docetaxel Taxotere ; plus Prednisolonne plus Strontium-89 vs. Docetaxel Taxotere ; plus Prednisolone plus Zoledronic acid Zometa ; plus Strontium-89 in Hormone Refractory Prostate Cancer metastatic to bone. Protocol version 7, 4th May 2007.
Haneke E. The treatment of atopic dermatitis with methylprednisolone aceponate MPA ; , a new topical corticosteroid. J Dermatol Treat 1992; 3 Suppl. 2 ; : 1315. [Product not listed in BNF, potency unclear] Harder F, Rufli T. Therapy of eczema. Once daily use of diflorasone diacetate in comparison to thrice daily use of betamethasone-17-valerate. in German ; . Schweiz Rundsch Med Prax 1983; 72: 12402. [Non-English language, potency of product unclear] Hersle K, Mobacken H. Once daily application of diflorasone diacetate ointment compared with betamethasone valerate ointment twice daily in patients with eczematous dermatoses. J Int Med Res 1982; 10: 4235. [Patients not limited to atopic eczema, potency unclear] Johansson EA, Stiger TR. Comparative efficacy of once a day diflorasone diacetate and twice a day betamethasone valerate ointment applications in eczematous dermatitis. Curr Med Res Opin 1984; 9: 25964. [Patients not limited to atopic eczema, potency unclear] Lawless JF, Stubbs SS. Comparative efficacy of once-aday diflorasone diacetate and t.i.d. hydrocortisone in treating eczematous dermatitis. Cur Ther Res Clinical Exp 1978; 23: 15965. [Patients not limited to atopic eczema, potency unclear] Lebwohl M. A comparison of once-daily application of mometasone furoate 0.1% cream compared with twicedaily hydrocortisone valerate 0.2% cream in pediatric atopic dermatitis patients who failed to respond to hydrocortisone: mometasone furoate study group. Int J Dermatol 1999; 38: 6046. [Hydrocortisone valerate 0.2% not in BNF, potency unclear] Levy A. Comparison of 0.1% halcinonide with 0.05% betamethasone dipropionate in the treatment of acute and chronic dermatoses. Cur Med Res Opin 1977; 5: 32832. [Different potencies] Lucky AW, Leach AD, Laskarzewski P, Wenck H. Use of an emollient as a steroid-sparing agent in the treatment of mild to moderate atopic dermatitis in children. Pediatr Dermatol 1997; 14: 3214. [CCT, groups not comparable] Meenan FO. The treatment of atopic dermatitis with clobestasol propionate. Ir Med J 1977; 70: 316. [Not RCT] Muzaffar F, Hussain I, Rani Z, Aziz A, Sultan B. Emollients as an adjunct therapy to topical corticosteroids in children with mild to moderate atopic dermatitis. J Pak Assoc Dermatol 2002; 12 April June ; : 648. [Not RCT].
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Serum and urinary free cortisol concentrations are mostly measured by RIA. Results of quality-assessment schemes show that performance of serum cortisol RIAs is relatively satisfactory, but not RIA measurements of urinary free cortisol [12]. The major problem of measuring urinary free cortisol is the large number of interfering substances in urine. Many steroids are metabolized and excreted as conjugates into urine, in concentrations possibly several orders of magnitude higher than those of the intact hormone. Because they may cross-react in immunoassays, conjugates form a particular problem in direct assays. HPLC methods that largely eliminate the problem of conjugate cross-reactivity have been described [11, 14, 15], but our initial studies indicated that certain commonly used drugs may interfere in these. Our HPLC cortisol method was optimized to eliminate interferences by drugs commonly encountered in hospital patients. If the sample contains high concentrations of carbamazepine or digoxin, the percentage of methanol in the mobile phase has to be slightly reduced; the only drawback of this change is a fairly long analysis time of 1 h per sample. Prednisolone also interferes, as appears also to be the case in other HPLC methods. Possible interference from other drugs not encountered in the present study should be considered. However, the provisional upper reference limit established for urinary free cortisol, 144 nmol day, is in agreement with previously reported values determined by HPLC [10, 13, 17]. Solid-phase extraction is a convenient way to extract steroids from urine, but there are large differences in extraction recovery of various columns Table 2 ; . The two most efficient columns are Bakerbond C18 and Isolute C18MF. In any case, the slight difference in recovery between cortisol and the IS must be taken into account in calculation of final results. Our method, with solid-phase extraction before HPLC, should further be useful for determination of other urinary glucocorticoids such as cortisone and 11-deoxycortisol Fig. 2A ; . The IS used, 6 -methylprednisolone, elutes quite late and does not overlap with other peaks.
TABLE 5. Retention of the antistaphylococcal activity of various creams in cotton rat noses over time.
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Than 3 lines ; at 12 months follow-up. In Group B 19 eyes ; , mean age was 69.2 years range 66 to 75 ; eyes had subfoveal and 3 had juxtafoveal lesions. 11 eyes 57.9% ; had stable or improved vision. In Group C 10 eyes ; , mean age was 81.7 years range 78 to 92 ; eyes had subfoveal and 2 had juxtafoveal lesions. 4 eyes 40% ; had stable or improved vision. Conclusion: In our study, a larger proportion of patients in the younger age groups 76.9% in Group A vs 57.9% in Group B vs 40% in Group C ; did better following PDT for symptomatic IPCV. Age may therefore, be an important prognostic factor in the treatment of this disease. However, in view of the retrospective nature of this study and small sample size, the true efficacy of PDT for IPCV and its relationship with age, would have to be evaluated with a larger, randomized controlled trial.
This perspective is supported by some recent psychosocial research in bipolar disorder. Since many outcome studies have found marked impairment in social and occupational functioning in bipolar disorder despite some symptomatic improvement pharmacologically, one might conclude that psychotherapeutic interventions are able to improve social and occupational functioning. Recent data support this hypothesis, which experienced clinicians already know: combined psychosocial pharmacological strategies are more effective than medication alone, espe!
PHARMACOKINETICS PK ; OF LASOFOXIFENE LASO ; , A NEXT GENERATION SELECTIVE ESTROGEN RECEPTOR MODULATOR. M. J. Gardner, PhD, D. Ouellet, PhD, C. Bramson, MD, D. Roman, MD, E. Randinitis, PhD, Pfizer, Groton, CT. BACKGROUND: LASO is in late stage development for the treatment of osteoporosis. The clinical pharmacology of LASO was characterized in more than 20 Phase 1 studies. METHODS: The effects of LASO on the PK PD of other drugs were evaluated. The effects of other drugs, food and hepatic impairment on LASO PK were studied in Phase I trials, whereas the effects of age, body weight, renal function and ethnicity were explored using a population PK approach. RESULTS: LASO PK appear to be linear over a broad range of doses. LASO is extensively metabolized with 2% of the dose excreted renally. The T1 2 at the 0.25 mg dose is 164 hr. Moderate hepatic impairment and inhibitors of CYP3A4 and CYP2D6, but not CYP2C9, only modestly increase exposure to LASO. Cholestyramine and food ingestion have no clinically significant effects on LASO PK. LASO did not affect the PK of CYP2E1 and CYP2D6 probe substrates or the PK of methylprednisolone, digoxin, or warfarin. The change in prothrombin time was slightly decreased when warfarin was co-administered with LASO. Age, body weight, renal function and ethnicity were not clinically important predictors of LASO PK. CONCLUSIONS: LASO is pharmacokinetically stable with little potential to interact with other concomitantly administered medications.
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